An Observational Study of Xeloda (Capecitabine) in Participants With Metastatic or Advanced Breast Cancer (XEPAD)

Roche

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Capecitabine

Study type: Observational

Funder types: Industry

Identifiers

NCT01725386

ML25640

Details and patient eligibility

About

This observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible participants will be followed for up to 24 months.

Enrollment: 274 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult female participants, >/= 18 years of age
• Cytologic/histopathologic confirmed diagnosis of metastatic breast cancer
• Prescribed capecitabine as in routine clinical practice
• Informed consent signed

Exclusion criteria

• Participation in any other clinical trial
• History of severe and unexpected reactions to fluoropyrimidine therapy
• Hypersensitivity to capecitabine or to any of the excipients of fluorouracil
• Known dihydropyrimidine dehydrogenase (DPD) deficiency
• Pregnant or lactating women
• Severe leucopenia, neutropenia, or thrombocytopenia
• Severe hepatic impairment
• Severe renal impairment (creatinine clearance below 30 ml/min)
• Treatment with sorivudine or its chemically related analogues, such as brivudine
• Refusal to give consent

Trial design

274 participants in 2 patient groups

Monotherapy

Description:

Capecitabine as monotherapy according to prescribing information and normal clinical practice.

Treatment:

Drug: Capecitabine

Combination Therapy

Description:

Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.

Treatment:

Drug: Capecitabine